Biosimilars: BIO Comments on FDA's Biosimilars User Fee Cover Sheet

Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Biosimilars User Fee Cover Sheet; Form 3792.” 

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.  BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. 

BIO appreciates the opportunity for public review and comment of the proposed biosimilars user fee form, so that the Agency’s implementation of a biosimilars pathway and review of 351(k) applications can proceed in a fair, transparent, and consistent manner.  In that vein, BIO would like to make a few comments about the proposed biosimilars user fee form:

        I.            Application Types and Abbreviations

We note that the user fee form refers to 351(k) applications as Biologic License  Applications (BLAs) for tracking and other purposes[1].  BIO believes that this terminology is confusing with respect to innovator BLA products and inconsistent with established and pending law. 

Under the Biosimilars Price Competition and Innovation Act of 2009 and the Biosimilar User Fee Technical Agreement (BsUFA), 351(k) products are referred to as “biosimilar biological products” or “interchangeable biosimilar biological products.”  Under the BPCIA, the term “BLA” is not used, but the phrase “biosimilar biological product application” is referenced in statute. 

For greater clarity and to better distinguish innovator applications and biosimilar applications, we suggest that FDA utilize the term “Biosimilar Biological product Licensing Application (BBLA).”  For the purposes of establishing interchangeability, FDA should refer to the product as an “Interchangeable Biosimilar biological product Application (IBLA).” We suggest that the terms BBLA and IBLA be used in this form, and for FDA application tracking purposes, indication of approval status, and general regulatory communications with regulated industry and the public.

This type of application naming and tracking is grounded in precedent as a similar distinction is made between New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). 

     II.            Request for Product Name

BIO notes that, since this form will, in many cases, be required early in the development program of biosimilars, the proper, trade, or proprietary name would not yet be established.  We therefore believe that the biosimilars user fee form should be consistent with the requirements for FDA Form 1571, as required for an investigational new drug application (IND), and request all available product names: trade, proper name, or code, as applicable. 

   III.            Request for Clinical Data Information

BIO also notes that the form requests information regarding whether the application will require clinical data.   This information is unnecessary, since the requirement to pay a user fee or the amount of the fee is not impacted by clinical data.  The requirement for clinical data is intended to be made by the Agency during the development process. 

Accordingly, BIO feels that this information is unnecessary with respect to the need to pay the biosimilar user fee or with respect to the amount that will be owed.

BIO appreciates this opportunity to comment on the “Biosimilars User Fee Cover Sheet; Form 3792.”  Specific, detailed comments are included in the following chart.  We would be pleased to provide further input or clarification of our comments, as needed.

[1] For example, the term BLA is referenced on the bottom of page 2 (“BLA STN Number”), middle of page 3 (Waiver), middle of page 4 (Submission Reference).